FDA.reportPublic FDA data

Methylphenidate Hydrochloride

Product NDC
31722-927
11-digit product format
317220927
Labeler code
31722
Product ID
31722-927_3547512f-45f7-4c6a-8fb0-2144eff24b11
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylphenidate Hydrochloride
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Camber Pharmaceuticals Inc.
Application
ANDA210354
Marketing category
ANDA
Marketing start
2018-03-01
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Methylphenidate Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4B3SC438HI
Rxcui1091152, 1091322, 1091389

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
143536be-f21a-464c-bc5a-163f5c171815Product name220250626
fd4d0878-dcea-3832-288e-e3bbbbe580ffProduct name920240516
435f0341-cf24-41d5-8fbf-c909821e5596Product name120230313
c9b6eabb-08d7-bb2d-e81a-06be3590b436Product name220221216
67aa32c6-44f4-50de-64dd-643e8caf420dProduct name620210622
50b24f34-96fa-4f1e-b262-b0baf4a4a440Product name420210513
cf83c421-eebe-4de2-b1a2-fd96e3dbfcf8Product name120200128
166d1d2d-dd55-4fdf-82e2-b83a3c5347c1Product name120190828
343a61d5-785d-cc27-a43a-0779da054d88Product name320190828
7607489b-cd15-3103-f3b1-d4283574d250Product name220190614
407f0cce-da29-4050-a512-2cabe9e5692dProduct name920190611
f7f4bf1e-7c67-46c6-8c42-9beb1a06b38eProduct name220190415
190572d9-6c7b-4b40-8172-c1b5f802c20fProduct name120180724
2948856e-f76e-d380-d9ed-b317efafbc98Product name520180423
c0aa09de-7aa1-4a98-8f70-62ec3c97c695Product name120170803
3317aade-2d6e-f159-9fe6-e8385a825178Product name320160829
0fe52203-83a7-4fed-a91f-8e47a22cf1d3Product name120160111

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-927-01Methylphenidate Hydrochloride100 in 1 BOTTLETABLET, CHEWABLE1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-927-01EA - Each31722-927710a801a-3bc1-4417-a208-332d6130892012018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-927METHYLPHENIDATE HYDROCHLORIDE TABLET, CHEWABLE [CAMBER PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 1 package rows20231011_bb73cd3e-aa7c-4f7e-826d-75e71fb6d1e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091322methylphenidate HCl 5 MG Chewable TabletPSN4de3567d-01e1-4be5-bfbc-0a4d6601a212103
1091322methylphenidate hydrochloride 5 MG Chewable TabletSCD4de3567d-01e1-4be5-bfbc-0a4d6601a212103
1091152methylphenidate HCl 10 MG Chewable TabletPSNbb73cd3e-aa7c-4f7e-826d-75e71fb6d1e05
1091389methylphenidate HCl 2.5 MG Chewable TabletPSNbb73cd3e-aa7c-4f7e-826d-75e71fb6d1e05
1091322methylphenidate HCl 5 MG Chewable TabletPSNbb73cd3e-aa7c-4f7e-826d-75e71fb6d1e05
1091152methylphenidate hydrochloride 10 MG Chewable TabletSCDbb73cd3e-aa7c-4f7e-826d-75e71fb6d1e05
1091389methylphenidate hydrochloride 2.5 MG Chewable TabletSCDbb73cd3e-aa7c-4f7e-826d-75e71fb6d1e05
1091322methylphenidate hydrochloride 5 MG Chewable TabletSCDbb73cd3e-aa7c-4f7e-826d-75e71fb6d1e05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-927-0131722092701100 TABLET, CHEWABLE in 1 BOTTLE (31722-927-01) 2018-03-010000-00-00NoNoCurrent